Cta
il y a 2 semaines
**Introduction**:
Science Talents is part of House of Talents, an international HR services group specialized in bottleneck professions. You will be working in a no-nonsense environment where team spirit, drive and eagerness to learn are key.
We are very open and communicative go-getters who are keen on results and quality.
To further strengthen our growth, we are constantly looking for new colleagues within Project Staffing.
Working as a consultant equals working with a fixed contract at Science Talents. You get the chance to work on different projects in your field of expertise and gain new experiences in life sciences, the chemical sector, and the food industry.
**Job description**:
Purpose of the role: The MIDI Clinical Trial Assistant (MCTA) works within the MIDI Clinical Operations team and is responsible for adequate administrative, logistic and operational support to clinical trials from start up until completion, within defined timelines and in accordance with ICH-GCP, other ethical and regulatory requirements and procedural documents. A MCTA works on one or several clinical trials in collaboration with trial team members as well as with the investigational sites and vendors involved in the clinical trials. A CTA can have an additional role and/or can take on an expert role/task (e.g. Payment Manager, Investigator Database Manager) and/or can be involved in local country activities for trial without being assigned to the clinical trial.
Accountabilities
Logistic, administrative and operational support
- Preparation, support and attendance of meetings e.g. kick-off meetings, trial team meetings, handover meetings, investigator meetings,take meeting minutes and follow-up on action items
- Set up and maintenance of share point, public drives, Microsoft Teams
- Support trial teams with the creation of presentations and communication, including distribution of documents for sign-off and follow-up
- Support in clinical trial payment process
- Support in submission process
- Investigational supplies support - communication and scheduling
- Enter information related to EC/CA approvals in CTA database
- Supporting trial study teams in audits/inspections
- Provide inspection readiness related support (including but not limited to crosschecks between systems like CTMS, Clinergize, TMF)
- Maintain trial team contact list, create distribution lists
- Support the team with operational aspects of the trial e.g. maintenance of trackers, access/accounts request and cancellation for sites and vendors, generating/downloading suppliers reports (e.g. ACI, BlueSky, ALMAC), communication regarding documents/updates/access and training for all systems (eg. IRT, Clinergize, BRAVE, ERT, etc.)
- Create, review and maintain training tracker based on Trial Training Plan
Set up and maintenance of the CTMS on country/site level
- Set up of trial countries and site personnel, incl. entering of relevant study/site staff responsibilities, start/end dates
- Responsible for site address/personnel change and notifications and updates to related forms, supplies, CTMS updates
- Support CTM to make updates and maintain accuracy in CTMS for planned and actual event dates, including ethics and regulatory approvals and ICF/protocol tracking
- Completing IDM CTMS information request forms - Running reports from CTMS
- Support CTM with the completion/Review of Site Release Checklist, incl. ensuring that all required documentation for site release and initiation are present
- Validate/cross-check TMF and CTMS information for consistency/ completeness
- Resolving GENIE checks, monthly QC document findings
Support in the maintenance and oversight of the Trial Master File
- Support in the TMF Documentation Vendor collaboration and communication
- Act as a TMF contributor by submitting records into the central TMF Staging Area and resolve any discrepancies prior to submission to the central TMF Staging Area
**Profile**:
- Minimum Education/Degree Requirements: Administrative qualification or equivalent by experience
- Regulatory and / or Organisational Requirements: Act in compliance to internal and external standards (e.g. ICH-GCP, Good Documentation Practice, SOPs, WIs and local procedures). Ensure that all interactions and engagements are carried out with the highest ethical and professional standards.
- Required Capabilities (Skills, Experience, Competencies): Good skills in:
- communication (cultural-sensitive, clear and transparent)
- conflict management - team work
- good English communication skills in writing, speaking and reading
- ability to prioritize - ability to coordinate and follow-up
- pro-activity and taking initiative
- understanding of legal/regulatory environment concerning sponsor TMF and ISF Management
- Job Expertise:
- work as a team member
- working in an international/intercultural/cross-functional environment
- technology learning agility in systems and processes, understanding system support processes
**Of
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